Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in DIAGNOdent readings
研究概览
简要总结
Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3
排除标准
- •Children with systemic diseases
- •Teeth with cavitated lesion involving dentin and enamel defects
结局指标
主要结局
Change in DIAGNOdent readings
时间窗: Baseline, 3 months, and 6 months
The measurements with the DIAGNOdent device that provides numerical values from 0 to 99
次要结局
- Change in ICDAS II scores(Baseline, 3 months, and 6 months)
- Change in Nyvad scores(Baseline, 3 months, and 6 months)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University